Lot-consistency Clinical Trial of Sabin Strain Inactivated Polio Vaccine

This study is a randomized, double-blinded, and positive-controlled clinical trial. A total of 1300 infants aged 2 months will be enrolled and assigned to 4 groups in a ratio of 1:1:1:1 to receive vaccination of 3 lots of investigational sIPV and control IPV manufactured by Sanofi Pasteur S.A respectively. Each subjects should finish the three-doses primary vaccination at the schedule of 2,3,4 months of age. Thirty-days safety observation after each dose of vaccination will be carried out. Venous blood should be collected from all the subjects before and 30 days after the three-doses primary vaccination, for the neutralizing antibody assay, and further to evaluate the immunogenicity.

Inclusion criteria

• Healthy infants aged 60-89 days;
• legal identity;
• Informed consent form has been signed by guardians.

Exclusion criteria

• Vaccination history of polio vaccine;
• Allergy history, history of asthma, including allergy history to vaccine or vaccine components, serious adverse reactions to the vaccine, such as urticaria, dyspnea, angioneurotic edema or stomachache, etc.;
• Congenital malformation or developmental disorder, genetic defect, serious malnutrition, etc.;
• Autoimmune disease or immunodeficiency/immunosuppression;
• Serious nervous system disorders (epilepsy, convulsion or tic) or mental disorders;
• Abnormal coagulation functions (such as coagulation factor deficiency, blood coagulation disease and blood platelet disorders) or obvious bruise or blood coagulation disorders diagnosed by the doctors;
• Receipt of immunosuppressant therapy, cytotoxic drug therapy and inhaled corticosteroid therapy (excluding the corticosteroid aerosol therapy for allergic rhinitis and surface corticosteroid therapy for acute non-complicated dermatitis);
• Receipt of blood products prior to this study;
• Receipt of other study drugs within 30 days prior to this study;
• Receipt of live attenuated vaccines within 14 days prior to this study;
• Receipt of subunit or inactivated vaccines within 7 days prior to this study;
• Acute diseases or acute exacerbation of chronic diseases within recent 7 days;
• Axillary temperature >37.0℃;
• Any other factors which are unsuitable for participation in the clinical trial as judged by the investigator.